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Laser-assisted Flapless Corticotomy in Accelerating Canine Retraction

Primary Purpose

Class II Division 1 Malocclusion, Maxillary Prognathism, Protrusion, Incisor

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Er:YAG laser
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Class II Division 1 Malocclusion focused on measuring Tooth movement, Acceleration of tooth movement, Er:YAG laser-assisted corticotomy

Eligibility Criteria

16 Years - 26 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Class II division 1 patients requiring orthodontic treatment with fixed appliances and a need for upper first-premolar extraction using a two-step retraction technique.
  • Permanent dentition with an age range from 16 to 24 years.
  • Healthy with no systemic conditions.
  • Adequate oral hygiene and healthy periodontal tissues
  • no previous orthodontic treatment
  • Absence of canine endodontic treatment.

Exclusion Criteria:

  • Bimaxillary dentoalveolar severe protrusion.
  • Previous orthodontic treatment.
  • Subject with psychological abnormalities.
  • Subject with systemic diseases.

Sites / Locations

  • Orthodontic Department, University of Hama Dental School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Laser-assisted corticotomy

Traditional treatment

Arm Description

Er:YAG laser beam was used to perform several perforations to the alveolar bone around the canine in one side of the mouth hoping that would accelerate canine retraction

Canines in this group were retracted by the conventional manner.

Outcomes

Primary Outcome Measures

Change in the canine retraction rate
The distance between the first molar labial hook and the canine bracket hook was recorded using Digital Boely gauge and then this distance was divided by the time that passed between two assessment points.

Secondary Outcome Measures

Change in the levels of pain and discomfort
A questionnaire was administered at the 1st, 3rd, 5th and 7th day after laser application. The questionnaire contained 5 questions (using 4-point Likert ordinal scales) to collect patients' responses on the following questions: Question 1: Do you feel pain during eating? Question 2: Do you feel pain during the day? Question 3: Do you feel pain that can awaken you during the night? Question 4: Do you feel swollen on the surgical side? The possible answers were: 1. No 2.Mild 3.Moderate 4. Severe For the first four questions, the higher the score, the worse the feeling was. Question 5: Which one of the following has caused more discomfort to you? 1. Extraction of premolars 2. Laser application 3.Both

Full Information

First Posted
March 18, 2020
Last Updated
March 21, 2020
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT04316403
Brief Title
Laser-assisted Flapless Corticotomy in Accelerating Canine Retraction
Official Title
Evaluation of the Efficacy of Laser-assisted Flapless Corticotomy in Accelerating Canine Retraction: A Split-mouth Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
February 15, 2015 (Actual)
Primary Completion Date
June 15, 2017 (Actual)
Study Completion Date
September 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Erbium lasers have been suggested to accomplish corticotomy without flap reflection due to their attractive advantages. The current trial aimed to evaluate the efficacy of laser-assisted flapless corticotomy in accelerating orthodontic tooth movement. The secondary aim was to evaluate the patients' responses to laser application. It was postulated that canine retraction after laser-assisted flapless corticotomy would be accomplished within a shorter period compared with the conventional canine retraction method, with no significant degree of pain and discomfort.
Detailed Description
Comprehensive orthodontic treatment with fixed appliances usually takes more than 18 months in mild and severe cases. Prolonged treatment time can cause many adverse effects such as pain, discomfort, external root resorption, white spots and dental caries. Decreasing the treatment time for tooth movement has been the focus of both the clinicians and the patients. For the last few decades, investigators have recommended many treatment approaches intending to reduce overall treatment time such as low friction and self-ligating bracket systems, low-level laser irradiation, electrical currents, pharmacological approaches, local platelet-rich plasma (PRP) injection and surgical approaches like dentoalveolar distraction and selective alveolar decortication or corticotomy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class II Division 1 Malocclusion, Maxillary Prognathism, Protrusion, Incisor
Keywords
Tooth movement, Acceleration of tooth movement, Er:YAG laser-assisted corticotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser-assisted corticotomy
Arm Type
Experimental
Arm Description
Er:YAG laser beam was used to perform several perforations to the alveolar bone around the canine in one side of the mouth hoping that would accelerate canine retraction
Arm Title
Traditional treatment
Arm Type
No Intervention
Arm Description
Canines in this group were retracted by the conventional manner.
Intervention Type
Procedure
Intervention Name(s)
Er:YAG laser
Intervention Description
This application was made before the onset of canine retraction in one side of the mouth
Primary Outcome Measure Information:
Title
Change in the canine retraction rate
Description
The distance between the first molar labial hook and the canine bracket hook was recorded using Digital Boely gauge and then this distance was divided by the time that passed between two assessment points.
Time Frame
10 minutes after laser application, one, two, four, 8 and 12 weeks after laser application
Secondary Outcome Measure Information:
Title
Change in the levels of pain and discomfort
Description
A questionnaire was administered at the 1st, 3rd, 5th and 7th day after laser application. The questionnaire contained 5 questions (using 4-point Likert ordinal scales) to collect patients' responses on the following questions: Question 1: Do you feel pain during eating? Question 2: Do you feel pain during the day? Question 3: Do you feel pain that can awaken you during the night? Question 4: Do you feel swollen on the surgical side? The possible answers were: 1. No 2.Mild 3.Moderate 4. Severe For the first four questions, the higher the score, the worse the feeling was. Question 5: Which one of the following has caused more discomfort to you? 1. Extraction of premolars 2. Laser application 3.Both
Time Frame
at the 1st day following laser application (10 minutes) and at the 3rd, 5th and 7th days following laser application

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Class II division 1 patients requiring orthodontic treatment with fixed appliances and a need for upper first-premolar extraction using a two-step retraction technique. Permanent dentition with an age range from 16 to 24 years. Healthy with no systemic conditions. Adequate oral hygiene and healthy periodontal tissues no previous orthodontic treatment Absence of canine endodontic treatment. Exclusion Criteria: Bimaxillary dentoalveolar severe protrusion. Previous orthodontic treatment. Subject with psychological abnormalities. Subject with systemic diseases.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samer T Jaber, DDS MSc
Organizational Affiliation
PhD student, Orthodontics Department, University of Damascus Dental School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rabab Al-sabbagh, DDS MSc PhD
Organizational Affiliation
Professor of Orthodontics, University of Hama, Hama, Syria
Official's Role
Study Chair
Facility Information:
Facility Name
Orthodontic Department, University of Hama Dental School
City
Hamah
ZIP/Postal Code
12JO76WH
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20152672
Citation
Fisher MA, Wenger RM, Hans MG. Pretreatment characteristics associated with orthodontic treatment duration. Am J Orthod Dentofacial Orthop. 2010 Feb;137(2):178-86. doi: 10.1016/j.ajodo.2008.09.028.
Results Reference
background
PubMed Identifier
15180086
Citation
Segal GR, Schiffman PH, Tuncay OC. Meta analysis of the treatment-related factors of external apical root resorption. Orthod Craniofac Res. 2004 May;7(2):71-8. doi: 10.1111/j.1601-6343.2004.00286.x.
Results Reference
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PubMed Identifier
24680026
Citation
Uribe F, Padala S, Allareddy V, Nanda R. Patients', parents', and orthodontists' perceptions of the need for and costs of additional procedures to reduce treatment time. Am J Orthod Dentofacial Orthop. 2014 Apr;145(4 Suppl):S65-73. doi: 10.1016/j.ajodo.2013.12.015.
Results Reference
background
PubMed Identifier
27484605
Citation
Hassan SE, Hajeer MY, Alali OH, Kaddah AS. The Effect of Using Self-ligating Brackets on Maxillary Canine Retraction: A Split-mouth Design Randomized Controlled Trial. J Contemp Dent Pract. 2016 Jun 1;17(6):496-503. doi: 10.5005/jp-journals-10024-1879.
Results Reference
background
PubMed Identifier
27869476
Citation
AlSayed Hasan MMA, Sultan K, Hamadah O. Low-level laser therapy effectiveness in accelerating orthodontic tooth movement: A randomized controlled clinical trial. Angle Orthod. 2017 Jul;87(4):499-504. doi: 10.2319/062716-503.1. Epub 2016 Nov 21. Erratum In: Angle Orthod. 2018 Jan;88(1):125.
Results Reference
background
PubMed Identifier
2133892
Citation
Hashimoto H. Effect of micro-pulsed electricity on experimental tooth movement. Nihon Kyosei Shika Gakkai Zasshi. 1990 Aug;49(4):352-61.
Results Reference
background
PubMed Identifier
33876339
Citation
Jaber ST, Al-Sabbagh R, Hajeer MY. Evaluation of the efficacy of laser-assisted flapless corticotomy in accelerating canine retraction: a split-mouth randomized controlled clinical trial. Oral Maxillofac Surg. 2022 Mar;26(1):81-89. doi: 10.1007/s10006-021-00963-x. Epub 2021 Apr 20.
Results Reference
derived

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Laser-assisted Flapless Corticotomy in Accelerating Canine Retraction

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